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U.S. Department of Health and Human Services

Medical Device Recalls
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Product: heartware
 
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HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst... 1 06/21/2022 Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU 1 06/03/2022 Medtronic Inc
Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi... 2 05/17/2022 Medtronic Inc
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 2 12/02/2023 Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 2 12/02/2023 Heartware, Inc.
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 2 12/02/2023 Heartware, Inc.
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP 2 12/02/2023 Heartware, Inc.
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